The ArtixASCEND Study
ConditionAcute Lower Limb Arterial Occlusion
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInari Medical
About this trial
This study is a post-market, prospective, multicenter, single-arm study to evaluate the safety and effectiveness of the Artix Thrombectomy System in patients with acute lower extremity arterial occlusions.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
Acute symptom duration ≤ 14 days
Lower limb arterial occlusion below inguinal ligament
Target lesion in native vessel
Disqualifiers
Life expectancy < 6 months
Prior major amputation in the target limb
Prior minor amputation in the target limb that is not completely healed or cannot bear weight
Non-thrombotic occlusion secondary to dissection, vasculitis, or target vessel trauma
Trial design
Design model
Single group
Treatments tested in this trial
Artix Thrombectomy System
DeviceTreatment of lower extremity arterial occlusions using the Artix Thrombectomy System.
Treatment groups
250 Participants
are divided into 1 treatment groupGroup A: Artix Thrombectomy SystemExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Primary Effectiveness Endpoint
Revascularization rate post-index procedure of target treatment area determined by an independent core lab.
Time frame
Immediately Following Index Procedure2
Primary Safety Endpoint
Periprocedural (within 48 hours) Artix Thrombectomy System-related major bleeding rate adjudicated as causal to the study device as determined by an independent Medical Monitor.
Time frame
48 HoursSecondary outcomes
1
Distal embolization SAEs
Time frame
Intra-procedure2
All-cause mortality
Time frame
1-month follow-up visit3
Limb salvage
Freedom from major amputation of the index limb
Time frame
1-month follow-up visit4
Amputation-free survival
Freedom from major amputation and all-cause mortality
Time frame
1-month follow-up visitSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov